BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183494 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09965
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN THE SET) DURING THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HOME PATIENT (HP) STATED HE WAS CONNECTED BEFORE HE PRESSED GO. THE HP MAY HAVE CONNECTED BEFORE PRIME WAS COMPLETE. THE TSR INSTRUCTED THE HP TO CYCLE THE POWER. THE HP WOULD USE NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING A SYSTEM ERROR 2240 ALARM. THE HP STATED HE STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY. THE PD RN WAS NOT NOTIFIED OF THE ALARM. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE